Join our team

CEVEC Pharmaceuticals, based in Cologne, is a leading provider of high-performance cell technology for the manufacturing of advanced biotherapeutics. The company’s product portfolio comprises platform technologies for gene therapy viral vectors, viral vaccines, exosomes, and complex recombinant proteins. Our unique ELEVECTA® platform is specifically designed for AAV manufacturing, while CAP® addresses adenoviral vectors, lentiviral vectors, oncolytic viruses and exosomes. CAP®Go is the platform of choice for complex recombinant proteins.

To ensure regulatory compliance and quality of our cell lines and services for our rapidly expanding customer base, we are looking for a

Director Quality Assurance and Regulatory Affairs (m/f/d)

You will be responsible for

  • Supervision of the Quality Management System and support of QA activities
  • Continuous monitoring of regulatory requirements in the field of mammalian cell substrates and production of biologics
  • Monitoring subcontracted cell bank testing programs and releasing cell banks
  • Regulatory due diligences by customers, collaboration partners and regulatory bodies
  • Conducting audits of our subcontractors
  • Management of customer requests regarding quality or regulatory related activities
  • Establishment and implementation of quality procedures in compliance with internal and external standards

Your qualification

  • Master / PhD in biotechnology, biology, pharmacy, biochemistry
  • > 3 years of experience in a QA function or equivalent in the pharmaceutical or biotechnology industry. Knowledge of regulatory and industry standards in the field of cell substrates, mammalian production platforms and / or gene therapy
  • Leadership experience is a plus
  • Fluent in English and German

If you are interested in the chance to take an active role in shaping a rapidly growing biotechnology company, please send your application (cover letter, resume and certificates) to the following address
(e-mail):

career@cevec.com
Cevec Pharmaceuticals GmbH
Gottfried-Hagen-Str. 60
51105 Cologne
Germany